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This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASP1941 group | Experimental | oral |
|
| placebo group | Placebo Comparator | oral |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ipragliflozin | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in HbA1c | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change from baseline in fasting plasma glucose | 16 weeks | |
| change from baseline in fasting serum insulin | 16 weeks | |
| safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hokkaido | Japan | |||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31606880 | Derived | Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12. |
| Label | URL |
|---|---|
| Link to results on Astellas Clinical Study Results Web site | View source |
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Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C572941 | ipragliflozin |
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| placebo |
| Drug |
oral |
|
| During treatment |
| Kansai |
| Japan |
| Kantou | Japan |
| Kyushu | Japan |
| TÅhoku | Japan |